Biopharma · FDA Approvals · Stock
PVLA Palvella
Palvella Therapeutics Inc is a clinical-stage biopharmaceutical company whose vision is to become the rare disease biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare skin diseases and vascular malformations for which there are no FDA-approv…
Assets on file: QTORIN rapamycin
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PVLAPalvellaPalvella Announces FDA Acceptance and Priority Review of QTORIN Rapamycin NDA with Feb 28 2027 PDUFA
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PVLAPalvellaPalvella Announces FDA Acceptance and Priority Review of QTORIN Rapamycin NDA with Feb 28 2027 PDUFA
The FDA accepted Palvella's NDA for QTORIN rapamycin for microcystic lymphatic malformations and granted Priority Review, setting a PDUFA target action date of February 28, 2027. The NDA is supported by positive Phase 3 SELVA study results meeting all six prespecified endpoints (all p<0.001). If approved, QTORIN rapamycin would be the first FDA-approved therapy for this indication.
PVLAPalvellaPalvella submits first module of rolling NDA for QTORIN rapamycin
Palvella has initiated its rolling NDA submission for QTORIN rapamycin in microcystic lymphatic malformations by filing the first module with FDA. The company remains on track to complete the full NDA submission in the second half of 2026 under Rolling Review granted after a pre-NDA meeting.
PVLAPalvellaPalvella: NDA submission for QTORIN rapamycin in microcystic LMs on track for 2H 2026
Palvella completed its pre-NDA meeting and received rolling review; the first module of the NDA has already been submitted. The company now expects to complete the full NDA submission in 2H 2026, positioning the product for potential FDA approval and U.S. launch in 1H 2027.
PVLAPalvellaPalvella presents SELVA/TOIVA data at ISSVA 2026
New Phase 3 SELVA and Phase 2 TOIVA data presented at ISSVA 2026 reinforce QTORIN rapamycin's efficacy in microcystic lymphatic malformations and cutaneous venous malformations. Company reiterated NDA filing planned for H2 2026 with potential approval targeted for H1 2027.
PVLAPalvellaPalvella: NDA submission for QTORIN rapamycin on track for H2 2026
FDA granted a pre-NDA meeting expected in Q2 2026. NDA submission remains on track for the second half of 2026, positioning the company for potential approval and U.S. launch in the first half of 2027.
PVLAPalvellaPalvella reports positive Phase 3 SELVA topline for QTORIN rapamycin in microcystic LMs
Phase 3 SELVA met its primary endpoint (mean mLM-IGA change +2.13, p<0.001) and all secondary endpoints (all p<0.001) in microcystic lymphatic malformations. Palvella plans NDA submission in H2 2026, with potential first U.S. approval in H1 2027. QTORIN rapamycin was well-tolerated with no drug-related serious adverse events.
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